From Investing.com:

Merck’s KEYTRUDA, an anti-PD-1 therapy, is being reviewed by the FDA for approval in combination with chemotherapy for treating advanced or recurrent endometrial carcinoma. The FDA has until June 21, 2024, to make a decision after accepting the new supplemental Biologics License Application from the company.

Clinical trial data from the Phase 3 NRG-GY018 study showed that KEYTRUDA plus chemotherapy significantly improved progression-free survival in patients with endometrial carcinoma, reducing the risk of disease progression or death by 46% for patients with mismatch repair proficient tumors and 70% for those with mismatch repair deficient tumors.

Dr. Ramez Eskander, the principal investigator of the study, emphasized the potential of KEYTRUDA to address the unmet need for patients with advanced or recurrent endometrial cancer and limited treatment options.

If approved, KEYTRUDA would be the first immunotherapy indicated for the frontline treatment of advanced endometrial cancer irrespective of mismatch repair status. Dr. Gursel Aktan, vice president at Merck Research Laboratories, highlighted the company’s commitment to making KEYTRUDA available to patients in need.

The trial was sponsored by the U.S. National Cancer Institute, designed and led by NRG Oncology with funding from the NCI and participation from all National Clinical Trials Network Groups. Merck provided funding and support through a Cooperative Research and Development Agreement with the NCI.

The FDA’s review of KEYTRUDA’s new indication is part of Project Orbis, which allows for concurrent submission and review of oncology drugs among international partners. Health authorities in Israel, Canada, Australia, Singapore, and Brazil are also reviewing the application.

In the U.S., KEYTRUDA already has two approved indications for endometrial cancer, both as a combination with LENVIMA and as a single agent for certain patients with advanced endometrial carcinoma. This is based on a press release from the company.



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